Phase 2 Study of DKN-01 in Colorectal Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Leap Therapeutics, Inc.
Study ID
NCT05480306
Phase
PHASE2
Status
Completed

Conditions

  • Colo-rectal Cancer
  • Colorectal Adenocarcinoma
  • Colorectal Cancer
  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DKN-01 — DRUG
    30 minute IV infusion (400mg) every two weeks with an additional loading dose in the first cycle of treatment
  • FOLFIRI — DRUG
    90-min IV infusion of irinotecan, leucovorin, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks
  • Bevacizumab — DRUG
    90-min IV infusion (5mg)
  • FOLFOX — DRUG
    2 hour IV infusion of oxaliplatin, folinic acid, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks

Study Details

This is a Phase 2 randomized, open-label, two-part, multicenter study with a safety run-in to evaluate efficacy and safety of DKN-01 plus FOLFIRI/FOLFOX and bevacizumab versus standard of care (SOC) \[FOLFIRI/FOLFOX and bevacizumab\] as second-line treatment of advanced CRC patients.

Key Dates

First listed
Jul 29, 2022
Start date
Aug 30, 2022
Status verified
Jul 2025
Primary completion
Jul 10, 2025
Completion
Jul 10, 2025

Study Design

Enrollment
188 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    DKN-01 + FOLFIRI or FOLFOX + bevacizumab
  • Active Comparator: Control
    FOLFIRI or FOLFOX + bevacizumab

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: approximately 6 months ]

Locations (25)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer CenterTucsonArizona85719-
UCLALos AngelesCalifornia90404-
Florida Cancer Specialists & Research Institute (FCS)Cape CoralFlorida33909-
Florida Cancer Specialists & Research InstituteFleming IslandFlorida32003-
Florida Cancer Specialists & Research InstituteGainesvilleFlorida32605-
Miami Cancer InstituteMiamiFlorida33176-
Florida Cancer Specialists & Research InstituteWellingtonFlorida33414-
Hematology Oncology ClinicBaton RougeLouisiana70809-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
Oncology Hematology Associates - SpringfieldSpringfieldMissouri65807-
Northwell HealthLake SuccessNew York11020-
Cornell UniversityNew YorkNew York10021-
Mount Sinai Medical Center - New YorkNew YorkNew York10029-
New York UniversityNew YorkNew York10016-
White Plains HospitalWhite PlainsNew York10601-
Messino Cancer CentersAshevilleNorth Carolina28806-
Duke University Medical CenterDurhamNorth Carolina27710-
Wake Forest UniversityWinston-SalemNorth Carolina27157-
Prisma Health Cancer Institute - FarisGreenvilleSouth Carolina29605-
Sanford Cancer CenterSioux FallsSouth Dakota57104-
Tennessee OncologyChattanoogaTennessee37404-
SCRI Oncology PartnersNashvilleTennessee37203-
Tennessee OncologyNashvilleTennessee37203-
MultiCare Tacoma General HospitalTacomaWashington98405-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Tucson, AZ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
The University of Arizona Cancer Center· Tucson, AZUCLA· Los Angeles, CAFlorida Cancer Specialists & Research Institute (FCS)· Cape Coral, FLFlorida Cancer Specialists & Research Institute· Fleming Island, FLFlorida Cancer Specialists & Research Institute· Gainesville, FLMiami Cancer Institute· Miami, FL

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